NCT06856525 · Y. Michael Shim, MD
Dissolved Phase HXe-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users
(ECIG)
What this study is about
A two-center, longitudinal assessment of 40 electronic cigarette users and 40 healthy controls at the initial visit and a follow-up visit 12 months later.
View original scientific description
A two-center, longitudinal assessment of 40 electronic cigarette users and 40 healthy controls at the initial visit and a follow-up visit 12 months later. This study will determine the impact of electronic cigarette use on pulmonary gas exchange capacity and then corroborate the Hyperpolarized Xenon MRI (HXeMRI) results with the cardiopulmonary stress test at the initial visit and a follow-up visit 12 months later.
Interventions
DRUG
Hyperpolarized xenon 129
Determine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI.
DIAGNOSTIC_TEST
Cardiopulmonary Stress Test
Exercise stress test to evaluate cardiac and pulmonary fitness.
DIAGNOSTIC_TEST
Pulmonary Function Test
Standard clinic pulmonary function test to evaluate lung function
DIAGNOSTIC_TEST
Chest CT
Clinical standard chest computer tomography to evaluate any lung tissue scars or air movement.
Primary outcome measures
Comparison between e-cig user vs. healthy participants at baseline and 12 month later
Time frame: baseline and 12 month follow-up
Hyperpolarized MRI (ventilation defect, RBC/Gas, Membrane/Gas, and RBC/membrane numbers) capillaries using HXeMRI, and corroborate the HXeMRI signatures with the CPET for 40 healthy participants and 40 e-cigarette users use at an initial visit (V1) and a follow-up visit 12-months later (V2).
Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up
Time frame: baseline and 12 months follow-up
Cardiopulmonary stress test maximum oxygen uptake
Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up
Time frame: Baseline and 12 months follow up
Pulmonary Function Test with 6 minute walk test
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ages between 18 and 35 years old. 2. At their baseline health 3. Ability to understand a written informed consent form and comply with the requirements of the study. 4. Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency. 5. Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine. 6. At baseline, normal spirometry with or without bronchodilator, plethysmograph lung volume, carbon monoxide diffusion capacity, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference. \-
Exclusion criteria
- History of any other lung disease 2. History of brain diseases including stroke and dementia, end-stage liver disease, coronary artery disease, renal failure 3. Acute infection of any kind previous 6 weeks 4. Pregnancy or a possibility of pregnancy 5. Anemia 6. Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteri
Where
- Durham, North Carolina
- Charlottesville, Virginia
Collaborators
Duke University, George Mason University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations